CN108778376B

CN108778376B - Opening and supply system for pre-filled containers, corresponding pre-filled container and method for implementing same

Info

Publication number: CN108778376B
Application number: CN201780012583.1A
Authority: CN
Inventors: R·孔索拉罗; 安吉洛·孔索拉罗; 拉吉夫·维尔巴德拉·卡布尔
Original assignee: Angela Patent Co ltd
Current assignee: Angela Patent Co ltd
Priority date: 2016-02-23
Filing date: 2017-02-23
Publication date: 2021-07-23
Anticipated expiration: 2037-02-23
Also published as: US11638783B2; WO2017145188A1; RU2018131128A; CN108778376A; JP7001607B2; US20190060573A1; JP2019507626A; KR20180116295A; BR112018016900A2; ITUB20160977A1; RU2721292C2; EP3419698A1; RU2018131128A3

Abstract

The invention relates to an opening and liquid supply system (100) for a prefilled container (10, 30) equipped with a supply end, comprising a coupling element (20), a connector (6) movable from a first position to a second position, and a movable protection (9); the coupling element (20) has a closed end (27) adapted to be pierced and a first guide (21) for guiding the movement of the connecting element (6) which is movable from a first position close to the closed end (27) to a second position remote from the end and vice versa; the connector (6) has a joint (7) for engaging with the protection (9) so as to move integrally in a second degree of freedom different from the first degree of freedom, and a first mating portion (11) for the first guide (21). The invention also relates to corresponding pre-filled containers equipped with such a system and to a method for implementing them.

Description

Opening and supply system for pre-filled containers, corresponding pre-filled container and method for implementing same

The present invention relates to an opening and supply system for pre-filled containers. In particular, the present invention relates to an opening system for pre-filled syringes or vials, which allows keeping the needle separate from the medicament until it is actually used.

In a syringe pre-filled with a given medicament, the same medicament stays inside the syringe for a long time.

Some medicaments are incompatible with the material from which the needle is made and may lose effectiveness or even become harmful, and sometimes their formulation or composition may generate residues that can clog the needle, preventing liquid from leaking out of the syringe at the time of use.

The object of the present invention is to eliminate this problem, so that the syringe can be used at any time by the user with a simple action.

A method for producing a syringe is known from the patent n.wo 2011001456. This method, which describes the application of the technique named BLOW FILL SEAL or BFS (shown in patents WO2007007178 and WO 2010143219), requires that the hermetic closure (or sealing: sealing step) occurs to form a cap or another closure element, which is connected to the hollow body of the container and is movable, facilitating breakage by means of the area having the thinner section.

In addition, it is known to place pre-filled syringes inside an external packaging in order to keep them sterile until the moment of use.

However, the packaging or cap covering the rod or the entire syringe has the disadvantage of being expensive during the production of the syringe, since it requires the additional use of plastic.

Thus, in the case of mass production, the use of plastics for the production of syringes, the dimensions of the rods (in the assembly line) to be sterilized and then stored and managed, and their subsequent handling, make syringes ecologically and economically untenable.

First, this method does not solve the above unfortunate drawback of the risk of contamination of the medical liquid by the needle.

There are also vials or syringes produced by the above-mentioned method BFS or other methods, which provide for the use of a fitting comprising a needle embedded in a threaded ring fitted with a protective cover for the needle: when the parts are screwed on, the membrane on the syringe or vial is perforated by the internal parts of the needle, allowing the communication of the medicament or liquid to be injected, contained in the vial or in the syringe, to prepare them for use.

However, such fittings are not readily available on the market, nor are they readily available.

Moreover, such fittings are often not completely reliable, with the risk of compromising the operation to be performed or the safety of the user who has to handle the vial or syringe.

There is therefore a need for a closure system for pre-filled syringes which allows containment and preservation of substances, which is easy to open by the user, complying with the specifications required by the operator, but which at the same time keeps its contents unchanged over time.

The present invention has been made to counteract the unfortunate shortcomings of the prior art.

In particular, the main object of the present invention is to develop an opening system for pre-filled syringes, a syringe equipped with such a system and a method for the production and assembly thereof which ensure the possibility of the same syringe being usable at any time by the user with simple actions.

Specifically, the present invention has the following objects: an opening system for pre-filled syringes, a syringe equipped with such a system and a method for its realization are achieved that allow keeping the needle separated from the medicament until the moment of use.

In more detail, the present invention has the following objects: an opening system for pre-filled syringes, a syringe equipped with such a system and a method for its realization are achieved, which allow to connect a needle to a hollow body containing a medicament, with the same opening operation.

Another object of the present invention is to devise an opening system for pre-filled syringes, a syringe equipped with such a system and a method for its realization, which have earlier embodiments but which nevertheless guarantee the achievement of the above mentioned objects.

Further objects of the present invention are an opening system equipped for pre-filled syringes, a syringe equipped with such a system and a method for its realization and assembly, which ensure a more practical use for the operator or the device to which it is applied.

The object is achieved by an opening system for a pre-filled syringe, a syringe equipped with such a system and a method for its realization and assembly.

Further application features of the method of the invention are highlighted in the respective dependent claims.

Advantageously, the system of the invention allows to provide syringes or containers for medical operations, without requiring any manipulation of the components of the same syringe by the user, even in the basic staffing of their construction.

This allows, for example, to manufacture a syringe for medical operations that is completely sterile and can therefore be subsequently used under optimum safety conditions in the hygienic and health conditions of the personnel, patients and staff involved.

Also advantageously, this is reflected in a significant reduction in the production costs of the syringe compared to the state of the art, of course, the other factors involved are equal.

Moreover, in an advantageous manner, the syringe obtained using the system of the invention has functional characteristics at least identical to those of known syringes, with respect to which, however, the above-highlighted advantages are maintained.

In detail, the subject of the invention is an opening and liquid supply system for a prefilled container equipped with a supply end, comprising a coupling element for coupling with the container, a connector movable from a first position to a second position, and a movable protection element.

Such a connection is suitable for accommodating needle holders, for example with standard components or with ad hoc components, or realized integrally with each other.

The coupling element has a first hollow end adapted for coupling with a supply end of a container and a second closed end adapted for puncturing; furthermore, such a coupling element has a first guide for guiding the movement of the connecting piece, which is movable from a first position near the second end to a second position near the first end and vice versa in a first degree of freedom.

The connector has a joint for engaging with the protector so as to move integrally with each other in a second degree of freedom different from the first degree of freedom, and a first mating portion for the first guide; in this way, advantageously, during the integral movement of the protector and the connecting piece, the first matching portion of the connecting piece moves along the first guide of the coupling element from the first position to the second position.

This allows keeping the pre-filled container sealed with the needle away from its supply end, preventing the liquid inside the container from being contaminated by the same needle, or the same liquid creating a blockage inside the needle.

At the same time, advantageously, the system of the invention allows to make the pre-filled container immediately ready for use, without forcing the operator to treat the sterile element prematurely.

Preferably, according to the invention, the connector is integral with the needle holder, equipped with a supply needle, suitable for piercing the second end of the coupling element, when the connector is in the second position.

Furthermore, according to the invention, the joint may comprise a protruding element adapted for sliding along a longitudinal groove on the inner surface of the protector.

Furthermore, according to the invention, the first guide may have a restriction so as to advantageously allow easy handling on the protector, without risk of blockage or breakage of the passage.

It is also advantageous if the coupling element can have a second guide for guiding the removal of the protection, while the protection can have a second mating portion corresponding to the second guide, so that the removal movement of the protection corresponds to the movement of the protection relative to the connector.

In this way, it is in fact possible to remove the protector from the pre-filled container and open the same container with a single necessary movement, making this operation intuitive for anyone.

In detail, the first guide of the coupling element may comprise a first thread, while the first mating portion of the connection piece may comprise a first counter-thread on the inner surface of the connection piece and corresponding to the first thread.

Advantageously, such a configuration is easily achieved during the execution of the method of forming the system, the counter-thread being moulded by the pressure of the connection on the threaded surface of the coupling element while the connection is still hot, thus reducing the production time of the same system.

In this case, the second guide of the coupling element may further include a second thread having a direction opposite to that of the first thread, while the second mating portion of the protector may include a second counter thread on an inner surface of the protector and corresponding to the second thread.

Advantageously, such a guide is easy to implement during the production method, according to the principles described above; furthermore, such a guide is also very easy to use by anyone, making the operation of opening the pre-filled container easier.

In other words, it is sufficient for the operator to unscrew the protection (for example, the cap) for activating the movement of the connector along the coupling element, causing the needle to break through the closed end of the coupling element: once the protector is removed, the pre-filled container is ready to be supplied with the liquid contained inside it.

The invention also relates to a pre-filled container for supplying a liquid, such as a medical liquid, comprising an opening and supply system according to the invention.

The objects and advantages and others that will appear hereinafter will become more apparent from the following description of the most preferred embodiments of the system of the invention, given by way of example and illustration, without limitation, with reference to the accompanying drawings, in which:

figure 1 shows a first cross-sectional view of the closure system of the present invention applied to a syringe in a first position;

FIG. 2 shows a cross-sectional view of the system of FIG. 1, with components visible in a transparent manner;

FIG. 3 shows a detail of FIG. 2;

FIG. 4 shows a second cross-sectional view of the system of FIG. 1 removed from the syringe;

FIG. 5 shows a cross-sectional view of the system of FIG. 1 in a second position;

FIG. 6 shows a detail of FIG. 5;

figure 7 shows, in a first variant, the system of the invention, in which it is applied to a vial;

FIG. 8 illustrates components of the system of FIG. 7;

FIG. 9 shows the system of the present invention with a standard needle applied;

FIG. 10 shows an exploded view of FIG. 9;

FIG. 11 shows an exploded view of the cross-section of FIG. 9 applied to a standard syringe;

FIG. 12 shows the system of FIG. 11 in a first position prior to puncture in cross-section;

fig. 13 shows the system of fig. 12 in a second position, in cross-section, with the needle in fluid communication, ready for use.

With reference to fig. 1-6, the opening system 100 for a pre-filled syringe 10 of the invention comprises a connecting piece 6 fitted with a first end 2 for sampling a medical liquid from a connector 20 suitable for being pierced and fitted with a second end 3 suitable for being connected to a needle 1 for supplying the medical liquid.

The needle 1 is held by: needle holder element 4 and is connected by a connector (e.g. Luer) to connector 6, in turn assembled with connector 20 and coupled to syringe 10.

The connector 6 is integral with the needle holder 4, according to the prior art (for example, by means of a Luer connection), and has: the engagement member 7, e.g. at least (a) longitudinal rib, is directed against a protection member 9 (e.g. cap 9) of the needle 1 on at least a part of the coupling surface 8.

The system 100 further comprises a connector or coupling element 20 adapted to couple a container of a medical liquid, such as a pre-filled syringe 10 realized by BFS technology, with the needle holder 4 by means of the connection 6.

Furthermore, the needle guard C is coupled to the cap 9, for example, embedding the needle guard C in the cap 9 while the cap 9 is still hot and thus malleable; in particular, this may occur, embedding only the base portion D of the needle guard C (fig. 7, 9, 10).

The coupling element 20 has a guide 21 corresponding to the first matching portion 11 on at least the surface 12 of the connecting element 6.

In particular, for example, the coupling element 20 has a substantially tubular shape, the cavity of which is coupled to the supply end of the container (for example, embedded in the supply end of the pre-filled syringe 10, in particular this may happen), while its outer surface has a thread 21, corresponding to the counter-thread 11 on the inner surface 12 of the connection 6 of the needle holder 4, when it is still hot and therefore malleable).

Preferably, the coupling element 20 has a restriction 22 of the guide 21 for the first mating portion 11 of the connection element 6 of the needle holder 4.

It is also preferred that a portion of the coupling element 20 has a guide 23 for the first matching portion 13 of the cap 9, for example a thread 23 and a counter-thread 13, wherein the direction is opposite to one of the threads 21 and the counter-thread 11, so that when the operator rotates the cap 9 clockwise, this is guided in a first direction a, corresponding to the cap 9 being removed from the rest of the system 100, while, as explained above, the connection 6 is guided with the needle holder 4 in a second direction B opposite to the first direction a.

In a first variant of the invention, shown in fig. 7, the opening system 100 of the invention is applied to a vial 30, which is always realised, for example, using BFS technology, in particular extruded.

The connection 6 of the system 100 has a substantially tubular shape, suitable to house a portion of the coupling element 20 inside it, and on its outer surface there are at least protruding elements 7 or longitudinal ribs, suitable to engage at least with longitudinal grooves (not shown) or corresponding seats on the inner surface of the cap 9 for protecting the needle 1, so that-rotating the cap 9 to remove it from the needle 1-the needle holder 4 rotates according to the same direction of the same cap.

Even though they are always shown in this way in the enclosed figures, the engagement members 7 do not have to be placed in correspondence with the connection members 6, but they must indeed be placed in order to engage with the inner surface of the cap 9.

The coupling element 20 shown in fig. 8 has a hollow volume consisting essentially of a first hollow cylinder 24 fitted with a first outer diameter and, preferably, also of a second hollow cylinder 25 fitted with a second outer diameter greater than the first outer diameter.

On the first cylinder 24 there is a guide 21, in the example shown in fig. 8 a thread, having a first direction, to which a counter thread 11 on the inner surface 12 of the connecting piece 6 of the needle holder 4 corresponds.

The first cylinder 24 has a hollow first end 26 adapted to face towards the supply end of the

container

10 or 30, and a second end 27, closed.

The second hollow cylinder 25 acts as a restraint for the thread 21 for the connecting piece 6.

Furthermore, preferably, the second hollow cylinder 25 has, on its external surface, a further thread 23 having a second direction opposite to the first direction, to which a second counter-thread 13 on the internal surface of the cap 9 corresponds.

As shown in the variation of fig. 11-13, the system 300 of the present invention may be adapted for application to a standard syringe 40, such as with a LUER connection.

In this case, the system 300 of the invention comprises only the connecting piece 6 and the modified coupling element 20, i.e. having the inner surface 28, for coupling by means of a Luer connection, in known systems, to a standard syringe 40.

In particular, the connection 6 has the same elements already described for the system 100.

As described above, the joint 7 is rotated by the operator and follows the thread of the guide 21 on the coupling element 20, breaking the closed end 27 by the inner end 41 of the needle 1, creating a connection of the liquid inside the syringe with a standard needle connected by a Luer connection.

During assembly and packaging of the container (visible in fig. 12), a needle 301 fitted with a needle holder 304 is added (using a standard connection, such as a Luer connection).

In operation, however, when an operator obtains a

container

10 or 30 or 40 containing a medical liquid to which the

opening system

100 or 300 of the present invention is applied, such a

system

100 or 300 is in a first position in which the connecting member 6 is separated from the supply end of the

container

10, 30 or 40 (fig. 1-3 and 12).

During the opening step, the operator acts on the cap 9, if on the container, or directly on the lug 7 (fig. 12 and 13), rotating in a direction of rotation, for example in a clockwise direction. In this way, the cap 9 starts to rotate, engaging with the engagement member 7 of the connecting member 6. In this way, the connecting piece 6 starts to rotate in the same direction: in this case, clockwise rotation. During the rotation of the connecting piece 6, it is guided by the first matching portion 11 along the path set by the guide 21 of the coupling element 20 towards the supply end of the

container

10 or 30 or 40 until the second end 27 of the supply element 20 is pierced with the first end 41 of the connecting piece 6 and reaches the second position, in which the

needle

1 or 301 communicates with the inside of the container 10 (fig. 5, 6 and 13) for supply.

At the same time, the connecting piece 6 is also moved longitudinally towards such a supply end of the

container

10, 30 or 40.

In this way, the

container

10 or 30 is detached from the cap 9 and possibly the needle guard C, ready for use, with the

needle

1 or 301 in contact with the medical liquid for the first time.

It is therefore clear from the description that has just been made that the opening system, the pre-filled container and the method for its production and assembly, the subject of the invention achieve the objects and achieve the advantages already mentioned.

During execution, changes may be made to the components of the system of the invention, including for example reversing the position of the guides and the (position of the) respective first mating portions to each other.

In this case, the program for implementing the system of the present invention described above will be changed accordingly.

Furthermore, it should be clarified that although the invention has been described with particular reference to a pre-filled disposable syringe and a vial for injection, the invention also extends to other liquid containers.

Obviously, many other changes may be made to the system in question without departing from the novel principles inherent in the inventive idea expressed herein, it being also clear that in the practical implementation of the invention, the dimensions, shapes and materials of the illustrated details may be anything, depending on the requirements, and replaced by other technically equivalent ones.

Where constructive and technical features mentioned in the appended claims are followed by signs or reference signs, such reference signs have been introduced for the sole purpose of increasing the intelligibility of the same claims and accordingly, they have no limiting effect on the interpretation of each element identified by way of example only by such reference signs.

Claims

1. A method for realizing an opening and liquid supply system (100) for a container (10, 30) equipped with a supply end, comprising a coupling element (20), a connecting piece (6) movable from a first position to a second position, and a movable protection (9), the connecting piece (6) being suitable for coupling with a needle holder (4),

the method comprises the following steps:

-providing in said coupling element (20) a hollow first end (26) suitable for coupling with a supply end of said container (10, 30), and a second end (27) closed and suitable for being pierced,

-providing a first guide (21) on the coupling element (20) for guiding the movement of the connecting piece (6) which is movable from a first position close to the second end (27) to a second position close to the first end (26) and vice versa, in a first degree of freedom,

-providing on said connector (6) a joint (7) for engaging with said protection (9) so as to move integrally along a second degree of freedom different from said first degree of freedom, and a first mating portion (11) for said first guide (21), so that during the integral movement of said protection (9) and said connector (6) according to said second degree of freedom, said first mating portion (11) of said connector (6) moves along said first guide (21) of said coupling element (20) from said first position to said second position,

-providing a second guide (23) on the coupling element (20) for guiding the removal of the protection (9),

-providing a second mating portion (13) on the protection (9) corresponding to the second guide (23) so that the removal movement of the protection (9) corresponds to the movement of the protection (9) with respect to the connector (6),

characterized in that the coupling element (20) couples with at least one of the container (10, 30), the protection (9) and the connector (6) when the container (10, 30), the protection (9) or the coupling element (20) is still malleable,

wherein the first guide of the coupling element (20) comprises a first thread and wherein the first mating portion of the connection piece (6) comprises a first counter-thread on the inner surface (12) of the connection piece (6) and corresponding to the first thread,

wherein the second guide of the coupling element (20) comprises a second thread having a direction opposite to the first thread, and wherein the second mating portion of the protection (9) comprises a second counter-thread on the inner surface of the protection (9) and corresponding to the second thread, and

wherein at least one of the first and second counter-thread is realized by pressing the protection (9) and the connection (6), respectively, still malleable, against the coupling element (20).

2. Method for realising a opening and liquid supply system (100) according to claim 1, characterised in that it comprises the following steps:

-providing said connection element (6) integral with a needle holder (4) equipped with a needle (1) suitable for piercing said second end (27) of said coupling element (20), when said connection element (6) is in said second position,

-providing a needle guard (C) for the needle holder (4),

-embedding at least a part of the needle guard (C) in the guard (9) while the guard (9) is still malleable.

3. Method for realizing an opening and liquid supply system (100) according to one of claims 1 or 2, characterized in that the first guide is realized by pressing a still malleable connecting piece (6) on the coupling element (20).

4. Method for realizing opening and liquid supply system (100) according to claim 1 or 2, characterized in that it comprises the following steps:

-the second guide of the coupling element (20) is realized by pressing the protection (9), still malleable, against the coupling element (20).

5. Method for implementing a pre-filled container (10, 30) comprising an opening and liquid supply system (100) implemented according to the method of one of claims 1-4.

6. Method of realising a pre-filled container (10, 30) according to claim 5, characterised in that it comprises the following steps:

-embedding the supply end of the container (10, 30) in the coupling element (20) while the coupling element (20) is still malleable.

7. An opening and liquid supply system (100) for a container (10, 30) equipped with a supply end, comprising a coupling element (20), a connecting piece (6) which can be moved from a first position to a second position, and a movable protection (9),

the connector (6) is adapted for coupling with a needle holder (4),

the coupling element (20) having a hollow first end (26) adapted for coupling with the supply end of the container (10, 30), and a closed second end (27) adapted to be pierced,

the coupling element (20) having a first guide (21) for guiding the movement of the connecting piece (6) movable from a first position near the second end (27) to a second position near the first end (26) and vice versa, in a first degree of freedom,

the connector (6) having an engagement member (7) for engaging with the protection member (9) so as to move integrally along a second degree of freedom different from the first degree of freedom, and a first mating portion (11) for the first guide (21) so that the first mating portion (11) of the connector (6) moves along the first guide (21) of the coupling element (20) from the first position to the second position during the integral movement of the protection member (9) and the connector (6) according to the second degree of freedom,

characterized in that it is achieved by coupling the coupling element (20) with at least one of the protection (9) and the connector (6) while the protection (9) or the coupling element (20) is still malleable,

the coupling element (20) further having a second guide (23) for guiding the removal of the protection (9), the protection (9) having a second matching portion (13) corresponding to the second guide (23), the removal movement of the protection (9) corresponding to the movement of the protection (9) relative to the connector (6) during the overall movement of the protection (9) and the connector (6) according to the second degree of freedom,

8. Opening and liquid supply system (100) according to claim 7, characterized in that said connection (6) is integral with a needle holder (4) fitted with a needle (1) suitable for piercing said second end (27) of said coupling element (20) when said connection (6) is in said second position.

9. Opening and liquid supply system (100) according to claim 8, characterized in that the needle holder (4) comprises a needle guard (C) coupled to the protection (9), at least a part of the needle guard (C) being embedded in the protection (9) when the protection (9) is still malleable.

10. Opening and liquid supply system (100) according to one of claims 7-9, wherein the engagement comprises a protruding element adapted for sliding along a longitudinal groove in the inner surface of the protection (9).

11. Opening and liquid supply system (100) according to one of claims 7-9, characterised in that the first guide (21) has a restriction.

12. A pre-filled container (10, 30) for supplying a medical liquid, the pre-filled container comprising an opening and liquid supply system according to one of the claims 7-11.

13. The pre-filled container (10, 30) according to claim 12, characterized in that the coupling element (20) is coupled with the container (10, 30) when the container (10, 30) is still malleable.